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FDAnews Drug Daily Bulletin

Mylan and Biocon Hit With Second CRL for Insulin Glargine Biosimilar

Sept. 12, 2019

The FDA has again shot down Mylan and Biocon’s copycat of Sanofi’s Lantus (insulin glargine) with a complete response letter, pending the completion of corrective actions at Biocon’s Malaysian insulin plant.

Bangalore, India-based Biocon, which developed the biosimilar, Semglee, with Mylan, said the FDA didn’t raise any scientific concerns, but called for completed CAPAs for problems identified during a pre-approval inspection of its insulin manufacturing facility in Malaysia in June. The agency’s investigators found 12 deficiencies in three separate units.

Biocon said the company is working to “complete these CAPAs to the satisfaction of the FDA.” and that it does not “anticipate any impact of this CRL on the commercial launching timing of our insulin glargine in the U.S.”

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